Evaluating the Use of a Medication 'Switch' vs Guideline-directed Interventions for Relieving Side Effects of Aromatase Inhibitors Among Breast Cancer Patients

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying ways to help women with early-stage breast cancer stay on their hormone treatment called aromatase inhibitors. These medications lower the chance of cancer coming back after surgery by reducing estrogen in the body. However, about half of women stop taking these medicines early because of side effects. This study is testing whether switching medications or following usual guidelines works better to relieve side effects, so women can continue their treatment and reduce the risk of cancer returning.

Women who might join this study are post-menopausal (meaning their periods have stopped), over 18 years old, and have a certain type of breast cancer that responds to hormone therapy. They should be planning to take aromatase inhibitors like letrozole, anastrozole, or exemestane for at least two more years. Participants will be closely monitored to see how well side effects are managed and to help them stay on their treatment. If you or a loved one fits these criteria and is starting or continuing this hormone therapy, this study may offer new ways to improve comfort and treatment success.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologic documentation of DCIS or invasive breast cancer by core needle or incisional biopsy.
• • The DCIS or invasive cancer must be estrogen receptor alpha (ER)-positive
• • The invasive cancer must be HER2-negative (IHC 0-1+, or with a FISH ratio of \<1.8 if IHC is 2+ or if IHC has not been done)
• • Clinical Stage I-III invasive breast cancer or DCIS
• • Patients for whom adjuvant treatment with one of the following would be clinically indicated: letrozole, anastrozole, exemestane
• • Patients who anticipate continuing with adjuvant endocrine therapy for a minimum of 2 years at the time of registration
• • Women over 18 years of age who are post-menopausal, defined as last menstrual period \>2 years prior to registration, or \>1 year prior to registration with FSH and estradiol in post-menopausal range.
• * Patients must meet the following clinical laboratory criteria:
• • Absolute neutrophil count (ANC) \>1,000/mm3 and platelet count \> 75,000/mm3
• • Total bilirubin \<1.5 x the upper limit of the normal range (ULN).
• • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3 x ULN.
• • Ability to give informed consent.
• Exclusion Criteria:
• • Prior endocrine therapy for any histologically-confirmed cancer or prevention of breast cancer in the last 10 years is not allowed.
• • Any other adjuvant therapy for breast cancer. Exception: Bisphosphonate or denosumab treatment for metabolic bone issues are allowed.
• • Patients who are prescribed tamoxifen as the first endocrine therapy rather than an aromatase inhibitor.
• • Women who are pregnant or lactating.
• • Prisoners.